Section 216-RICR-40-15-1.2 - DefinitionsA. Wherever used in this Part the following terms shall be construed as follows:1. "ACPE" means Accreditation Council for Pharmacy Education.2. "Act" means R.I. Gen. Laws Chapter 5-19.1 entitled, "Pharmacies."3. "Active ingredient" means any component that provides pharmacological activity or other direct effect in the diagnosis, cute, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or animals.4. "Actively reports" means reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical but no later than thirty (30) days of identification of the error.5. "Administer" or "Administration" means the direct application of - medications to the body of a patient or research subject by a practitioner by injection, inhalation, ingestion, or any other means.6. "Adverse drug reaction" means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.7. "Assisted living residence licensed at the M-1 level" or "Assisted living residence" means a publicly or privately operated residence that provides directly or indirectly by means of contracts or arrangements personal assistance to meet the resident's changing needs and preferences, including central storage and/or administration of medications, lodging, and meals, to six (6) or more adults who are unrelated to the licensee or administrator, excluding however, any privately operated establishment or facility licensed pursuant to R.I. Gen. Laws Chapter 23-17 and those facilities licensed by or under the jurisdiction of the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, the Department of Children, Youth, and Families, or any other state agency. Assisted living residences include sheltered care homes, board and care residences, and any other entity by any other name providing the above services.8. "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.9. "Auto-substitute" means the replacing of the prescribed product with either a generic product, another brand of the prescribed product, a product with the same active ingredient but different inactive ingredients or a different drug within the same therapeutic class as the prescribed product, without being required to obtain prescriber authorization.10. "Automated dispensing system" means a computerized system for dispensing prepackaged medications in manufacturer labeled, unit-of-use doses.11. "Automated filling system" means an automated system used within a pharmacy to assist in filling a prescription drug order by selecting, labeling, filling, or sealing medication for dispensing. An "automated filling system" shall not include automated devices used solely to count medication or vacuum tube drug delivery systems.12. "Automated pharmacy system" means a mechanical system, located within or adjacent to the prescription department, or at a remote location, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information.13. "Automated storage and distribution devices" means a mechanical device that delivers drugs other than by administration, and uses automated data processing technology to: a. Provide effective storage and security of drugs contained in the device;b. Limit access to authorized individuals;c. Record the identity of all personnel who access the drugs stored within the device;d. Provide documentation of storage and removal of contents;e. Provide ongoing documentation that monitors proper delivery of drugs to ensure patient safety;f. Comply with Rhode Island General Laws and Regulations.14. "Batch compounding" means the act of compounding multiple containers/doses of a drug product or other material with uniform character and quality, within specified limits, that are prepared in anticipation of physician/prescription drug orders or approved protocol/procedure based on routine, regularly observed prescribing patterns.15. "Beyond use dating" means:a. The date or time beyond which a drug preparation is not recommended to be dispensed, administered, stored, or transported.b. Beyond Use Dating shall be determined from the date and time the drug preparation is compounded. Administration times (also known as "hang times") shall not exceed twenty-four (24) hours from the established beyond use dating on the dispensed product unless shorter administration times are required by the manufacturer's specifications/literature.16. "Biological product"' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings as defined in the Public Health Service Act, 42 U.S.C. § 262.17. "Biosimilar" means a product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.18. "Blister packages" means multi-dose containers of a specific medication repackaged by the pharmacy in accordance with §1.1.7 of this Part and intended for a specific patient.19. "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.20. "Blood component" means that part of blood separated by physical or mechanical means.21. "Board" means the Board of Pharmacy within the Department of Health established pursuant to R.I. Gen. Laws § 5-19.1-3.22. "Call center operation" means any operation that functions as a shared order processing facility but is not licensed as a pharmacy.23. "Central fill pharmacy" means the pharmacy that fills the prescription order for delivery in accordance with an agreement with another pharmacy or pharmacies.24. "Change of ownership" means: a. In the case of a pharmacy, manufacturer or wholesaler which is a partnership which results in a new partner acquiring a controlling interest in the partnership;b. In the case of a pharmacy, manufacturer or wholesaler which is a sole proprietorship, the transfer of the title and property to another person;c. In the case of a pharmacy, manufacturer or wholesaler which is a corporation: (1) A sale, lease exchange, or other disposition of all, or substantially all of the property and assets of the corporation; or(2) A merger of the corporation into another corporation; or(3) The consolidation of two (2) or more corporations, resulting in the creation of a new corporation; or(4) In the case of a pharmacy, manufacturer or wholesaler which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in the corporation; or(5) In the case of a pharmacy, manufacturer or wholesaler which is a nonbusiness corporation, any change in membership which results in a new person acquiring a controlling vote in the corporation.25. "Clinic" means a health facility providing healthcare services to individuals associated with a college or university.26. "Collaborative pharmacy practice" is that practice of pharmacy pursuant to R.I. Gen. Laws Chapter 5-19.2 whereby one (1) or more licensed pharmacist(s), with advanced training and experience relevant to the scope of collaborative practice, agrees to work in collaboration with one (1) or more physician(s) for the purpose of drug therapy management of patients, such management to be pursuant to a protocol or protocols authorized by the physician(s) and subject to conditions and/or limitations as set forth by the Department. A health care professional who has prescribing privileges and is employed by a collaborating physician may be in such an agreement.27. "Collaborative practice agreement" is a written and signed agreement, entered into voluntarily, between one (1) or more pharmacist(s) with advanced training and experience relevant to the scope of collaborative practice and one (1) or more physician(s) that defines the collaborative pharmacy practice in which the pharmacist(s) and physician(s) propose to engage. Collaborative practice agreements shall be made in the best interest of public health.28. "Collaborative practice committee" shall consist of six (6) individuals: three (3) individuals to be appointed by the Board of Pharmacy from nominees provided by the Rhode Island Pharmacists Association; and three (3) individuals to be appointed by the Board of Medical Licensure and Discipline from nominees provided by the Rhode Island Medical Society. The Collaborative Practice Committee shall advise the Director on all issues pertinent to the regulation of collaborative practice agreements.29. "Complex non-sterile drug preparation" means:a. A compounded drug preparation which requires special training, special environment, special facilities, or equipment.b. Compounding techniques and procedures that may present an elevated risk to the compounder or the patient.c. Complex Non-Sterile Drug Preparation shall be consistent with the category of complex non-sterile compounding described in current USP chapter 795.30. "Compounded sterile preparations" or "CSPs" means a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.31. "Compounding" shall be the act of combining two (2) or more ingredients as a result of a practitioner's prescription or medication order occurring in the course of professional practice based upon the individual needs of a patient and a relationship between the practitioner, patient, and pharmacist. Compounding does not mean the routine preparation, mixing, reconstitution or assembling of drug products that are essentially copies of a commercially available product. Pharmacy compounding includes the preparation of drugs or devices pursuant to a prescription or medication order or in anticipation of prescription or medication orders based upon routine, regularly observed prescribing patterns.32. "Compounding accountability document" means:a. Formulation of the compounded product.b. Lot numbers, expiration dates, and beyond use dates of all chemicals used in the preparation of the finished compounded product.c. Initials to identify pharmacist and technician involved in the preparation of the finished compounded product.33. "Confidential information" means healthcare and other information maintained by the pharmacist in the patient's records, which is deemed confidential by virtue of the provisions of R.I. Gen. Laws Chapter 5-37.3, and any other Federal or State law.34. "Contact hour" means a unit of measure of educational credit as defined by ACPE.35. "Consultant pharmacist" means a pharmacist licensed to engage in the practice of pharmacy in this State who is responsible for developing, coordinating, and supervising pharmaceutical services in a nursing facility, assisted living residence, medical institution, or hospice care facility.36. "Continuing education" means accredited or approved post-licensure professional pharmaceutical education designed to maintain and improve competence in the practice of pharmacy, pharmacy skills, and preserve pharmaceutical standards for the purpose of protecting public health, safety, and welfare. Continuing education programs shall address topics and subject matter areas which are pertinent to the contemporary practice of pharmacy.37. "Continuing education unit" (CEU) means a unit of measure of educational credit which is equivalent to ten (10) hours.38. "Controlled substance" means a drug or substance, or an immediate precursor of such drug or substance, so designated under or pursuant to the provisions of R.I. Gen. Laws Chapter 21-28.39. "Correctional facility" means any facility in the State of Rhode Island for the confinement or rehabilitation of offenders or individuals charged with or convicted of criminal offenses.40. "Counseling" means the oral communication by the pharmacist of information, as defined in the rules of the Board, to the patient or care giver, in order to improve therapy by ensuring proper use of drugs and devices.41. "COVID-19" means the disease cause by the novel coronavirus SARS-CoV-2.42. "Deliver" or "Delivery" means the actual, constructive, or attempted transfer from one (1) person to another of a drug or device whether or not there is an agency relationship.43. "Department" means the Rhode Island Department of Health.44. "Digital signature" means an electronic signature based upon cryptographic methods of originator authentication, and computed by using a set of rules and a set of parameters that identify the signer so that the integrity of the data can be verified.45. "Delivery pharmacy" means the pharmacy that delivers the filled prescription medication to the patient.46. "Device" means an instrument, apparatus, and contrivances, including their components, parts and accessories, intended: a. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or b. To affect the structure or any function of the body of man or other animals.47. "Director" means the Director of the Rhode Island state Department of Health or his/her subordinates to whom the Director has delegated the powers and duties vested in the Director by these Regulations. The terms Department or Director may be used interchangeably unless clearly indicated otherwise by the context of the sentence in which it appears.48. "Discontinuance" means the action of terminating by discontinuing, suspending, or revoking any license for good and sufficient cause.49. "Dispensary" shall have the same meaning as "clinic."50. "Dispense" or "Dispensing" means the interpretation of a prescription or order for a drug, biological, or device and, pursuant to that prescription or order, the proper selection, measuring, compounding, labeling, or packaging necessary to prepare that prescription or order for delivery or administration.51. "Dispense as written" means the prescriber's instructions regarding authorization for substitutions with generic equivalents or ordering of the specific prescribed medication with instructions on the prescription stating "DO NOT SUBSTITUTE".52. "Dispensing error" means one (1) or more of the following discovered after the final verification by the pharmacist and after receipt of the drug by the patient:a. Variation from the prescriber's prescription drug order, including but not limited to:(2) Incorrect drug strength;(3) Incorrect dosage form;(4) Incorrect patient; or(5) Inadequate or incorrect packaging, labeling, or directions.b. Failure to exercise professional judgment in identifying and managing:(1) Known therapeutic duplication;(2) Known drug-disease contraindications;(3) Known drug-drug interactions;(4) Incorrect drug dosage or duration of drug treatment;(5) Known drug-allergy interactions;(6) A clinically significant, avoidable delay in therapy; or(7) Any other significant, actual, or potential problem with a patient's drug therapy.c. Delivery of a drug to the incorrect patient.d. Variation in bulk repackaging or filling of automated devices, including but not limited to: (2) Incorrect drug strength;(3) Incorrect dosage form; or(4) Inadequate or incorrect packaging or labeling.53. "Dispensing error analysis" means a review of the findings collected and documented on each dispensing error, assessment of the cause and any factors contributing to the dispensing error, and any recommendation for remedial action to improve pharmacy systems and workflow processes to prevent or reduce future errors.54. "Distribute" means the delivery of a drug other than by administering or dispensing.55. "Drug" means: a. Articles recognized in the official United States Pharmacopeia, or the official Homeo-pathic Pharmacopeia of the United States;b. Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, woman or other animals;c. Substances (other than food) intended to affect the structure of any function of the body of man, woman or other animals;d. Substances intended for use as a component of any substances specified here above or as a "Error! Reference source not found." or "Error! Reference source not found." defined in these Regulations, but not including devices or their component parts or accessories.56. "Drug regimen review" includes but is not limited to the following activities: a. Evaluation of the prescriptions and patient records for:(2) Rational therapy-contraindications;(3) Reasonable dose and route of administration;(4) Reasonable directions for use, and(5) Evaluation of the prescriptions and patient records for duplication of therapy.b. Evaluation of the prescriptions and patient records for interactions:(4) Adverse drug reactions, and(5) Idiosyncratic reactions.c. Evaluations of the prescriptions and patient records for proper utilization (including over-and under-utilization), and optimum therapeutic outcomes.57. "DEM" means the Rhode Island Department of Environmental Management.58. "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.59. "Drugs establishment" refers to any business eligible to hold a Federal Registration of Drug Establishment, issued by the Federal Food and Drug Administration of the United States Department of Health and Human Services (or a successor agency).60. "Drug" has the same meaning set forth in R.I. Gen. Laws § 5-19.1-2(k).61. "Drug therapy management" means the review, in accordance with a collaborative practice agreement, of drug therapy regimen or regimens of patients by one (1) or more licensed pharmacist(s) for the purpose of initiating, adjusting, monitoring, or discontinuing the regimen. Decisions involving drug therapy management shall be made in the best interests of the patient. In accordance with a collaborative practice agreement, drug therapy management may include:a. Initiating, adjusting, monitoring, or discontinuing drug therapy;b. Collecting and reviewing patient histories;c. Obtaining and checking vital signs, including pulse, height, weight, temperature, blood pressure, and respiration; andd. Ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and providing such evaluation does not include any diagnostic component.62. "Electronic medical record" (eMAR) is an electronically stored report that serves as a record of the drugs administered to a patient at a facility by a health care professional. The eMAR is a part of a patient's permanent record on his/her medical chart.63. "Electronic signature" means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.64. "Electronic transmission prescription" means any prescription, other than an oral or written prescription, that is electronically transmitted from a practitioner authorized to prescribe to a pharmacy without alteration by a third (3rd) party unless authorized by the prescribing practitioner or from one (1) pharmacy to another pharmacy.65. "Emergency drug kit" means a select supply of drugs and/or biologicals located at a nursing facility, assisted living residence, medical institution, or hospice care facility, except as prohibited by other statutes or Regulations, for the immediate administration to patients upon the medical order of an authorized prescriber.66. "Equivalent and interchangeable" means having the same generic name, dosage form, and labeled potency, meeting standards of the United States Pharmacopoeia or National Formulary, or their successors, if applicable, and not found in violation of the requirements of the United States Food and Drug Administration, or its successor agency, or the Rhode Island Department of Health.67. "Facsimile (FAX) prescription" means a written prescription or order that is transmitted by an electronic device that sends the exact image to the receiver (pharmacy) in a hard copy form.68. "FDA-approved product" means any drug or device that has received United States Food and Drug Administration (FDA) approval, including being manufactured in an FDA-approved facility.69. "Financial interest" means financial benefit gained by any practitioner with authority to prescribe drugs and includes such benefit derived by a spouse or dependent child.70. "Foreign pharmacy graduate" is a pharmacist whose undergraduate pharmacy degree was conferred outside the United States by a pharmacy school listed in the World Directory of Schools of Pharmacy published by the World Health Organization. The United States, as used here, includes the fifty (50) States, the District of Columbia, and Puerto Rico.a. "FPGEC" means the Foreign Pharmacy Graduate Equivalency Commission.b. "FPGEE" means the Foreign Pharmacy Graduate Equivalency Examination.c. "TOEFL" is the Test of English as a Foreign Language, as given by the American College Testing (ACT), or its successor, and certified by the FPGEC.d. "Test of Spoken English (TSE)" means the test of spoken English administered by the Educational Testing Service.71. "High-risk compounded sterile products" means products compounded under conditions that are at a high risk of becoming contaminated with an infectious microorganism. High risk conditions shall include: using non-sterile ingredients or a non-sterile device in the preparation of the final product; sterile contents that lack effective antimicrobial preservatives and packaging containers that are exposed to air quality inferior to ISO Class 5 before sterilization; procedures such as weighing and mixing conducted in air quality inferior to ISO Class 7; the chemical purity and content strength of ingredients used are not verified to meet their original or compendial specifications in packages of bulk ingredients.72. "Hazardous drug" means any drug identified on the NIOSH or DEM lists that has the potential to cause carcinogenicity, teratogenicity, developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.73. "Hospice care facility" means an inpatient setting where palliative and supportive services to the terminally ill and their families are provided.74. "Hospital" means a facility with a governing body, an organized medical staff and a nursing service providing equipment and services primarily to inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy, licensed pursuant to R.I. Gen. Laws Chapter 23-17.75. "Immunizing pharmacist" means a pharmacist who is certified to administer adult and pediatric vaccinations in accordance with these Regulations.76. "Institutional pharmacy" means any pharmacy:b. Off-site and contracted with any hospital, clinic or dispensary in which drugs are compounded or dispensed to its patients or patients of another licensed in-patient healthcare facility with whom it has a contract.77. "Interchangeable biological product" means biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.78. "Intern" means a graduate of an Accreditation Council for Pharmaceutical Education (ACPE)-accredited program of pharmacy, or a student enrolled in a professional ACPE-accredited program of pharmacy or a graduate of a foreign college of pharmacy who has obtained full certification from the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National Association of Boards of Pharmacy.79. "Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.80. "Internship" means that period of training of an intern, under the direction of the preceptor, which is required for licensure to engage in the practice of pharmacy.81. "Investigational drug" means any drug which has not been approved for use in the United States, but for which an investigational drug application has been approved by the Food and Drug Administration (FDA).82. "ISO" means an air quality classification from the International Organization for Standardization.83. "Legend drugs" means any drugs that are required by any applicable Federal or State law or Regulation to be dispensed on prescription only or are restricted to use by practitioners only.84. "Limited-function test" means those tests listed in the Federal Register under the Clinical Laboratory Amendments of 1988 (CLIA) as waived tests.85. "Live hours" means hours acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences or workshops.86. "Low-risk compounded sterile products" means a product compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using no more than three (3) sterile ingredients added to one (1) package.87. "Manipulations" means aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.88. "Manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging.89. "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug or poisons.90. "Manufacturing" means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substances or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists, practitioners, or other persons.91. "Medical institution" means any hospital, clinic or dispensary.92. "Medication error" means any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems including, but not limited to: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.93. "Medication administration record" or "MAR" is a report that serves as a record of the drugs administered to a patient at a facility by a health care professional. The MAR is a part of a patient's permanent record on their medical chart.94. "Medication orders" or "Orders" means a written, verbal or electronically transmitted order for drugs and devices from an authorized practitioner in the State of Rhode Island for the dispensing and administration of a drug.95. "Medium-risk compounded sterile products" means a product compounded under low-risk conditions with the addition of at least one (1) of the following conditions: compounding a CSP that will be administered to either multiple patients or to one (1) patient on multiple occasions; and the compounding process involves complex aseptic manipulations or an unusually long duration.96. "Multi-drug single-dosing container" means a container that is a customized single-dosing package labeled by a pharmacy for a specific patient, and such package contains one (1) or more solid, oral dosage form drugs to be administered to or taken by a specific patient at the same dosage time from a single container.97. "NABP" means National Association of Boards of Pharmacy.98. "NIOSH" means National Institute for Occupational Safety and Health.99. "Nonlegend" or "Nonprescription drugs" means any drugs that may be lawfully sold without a prescription.100. "Nonresident pharmacy" means a pharmacy located outside Rhode Island in any State in the United States or any Province or Territory of Canada that ships, mails, or delivers prescription drugs and/or devices to a patient or person in Rhode Island.101. "Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services.102. "Nuclear/radiologic pharmacy practice" refers to a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.103. "Nursing facility" means a place, however named, or an identifiable unit or distinct part thereof that provides twenty-four (24) hour in-resident nursing, therapeutic, restorative or preventive and supportive nursing care services for two (2) or more residents unrelated by blood or marriage whose condition requires continuous nursing care and supervision.104. "Outsourcing facility" means a facility at one (1) geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the requirements of §503B of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 353b.105. "Parenteral pharmacy practice" refers to admixtures of sterile parenteral solutions and dispensing of same intended for administration to patients in healthcare facilities and in the home.106. "Patient profile" means a patient record system that is maintained by all pharmacies for patients for whom prescriptions are dispensed. The patient profile shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing.107. "Patient safety organization" (PSO) means an organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 (Pub. Law 109-41) and is credentialed by the Agency for Healthcare Research and Quality.108. "Perforated unit-dose blister packages" means unit-dose containers of a specific medication prepared in multi-dose containers by the manufacturer or pharmacy that includes the identity, quantity and strength of the product, name of the manufacturer, lot number and expiration date and labeled by the pharmacy for a specific patient.109. "Person" means an individual, corporation, government, subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity.110. "Pharmaceutical assistance program (PAP) medication" means a noncontrolled manufacturer-prepared medication that is shipped to a practitioner for a specific "medically indigent" patient, generally defined as those with low income, without insurance, and ineligible for public programs.111. "Pharmaceutical care" is the provision of drugs and other pharmaceutical services intended to achieve outcomes related to cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. Pharmaceutical care includes the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or device in response to a prescription after appropriate communication with the patient.112. "Pharmaceutical organization" means any profit or non-profit organization that advocates, lobbies, solicits business, or provides support services to any private or public sector organization, or business within the various disciplines of the pharmacy profession, including but not limited to State pharmacy associations, national pharmacy associations, accrediting organizations and suppliers.113. "Pharmacist" means an individual licensed to engage in the practice of pharmacy in the State of Rhode Island pursuant to R.I. Gen. Laws §519.1-14.114. "Pharmacist care services" is the provision by a pharmacist of patient care activities within this State or into this State, as defined by this Part, with or without the Dispensing of Drugs or Devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.115. "Pharmacist-in-charge" means a pharmacist licensed in the State of Rhode Island designated by the owner as the person responsible for the operation of a pharmacy in conformance with all laws and Regulations pertinent to the practice of pharmacy and who is personally in full and actual charge of such pharmacy and personnel.116. "Pharmacist with advanced training and experience relevant to the scope of collaborative practice" means, a licensed pharmacist in the State of Rhode Island with post-graduate educational training. Such training shall include, but not be limited to, residency training; board certification; certification from an accredited professional organization educational institution; or any other continuing education provider or employer sponsored training approved by the Director relevant to the proposed scope of the collaborative practice agreement.117. "Pharmacy" means that portion or part of a premises where prescriptions are compounded and dispensed, including that portion utilized for the storage of prescription or legend drugs.118. "Pharmacy and therapeutics committee" means the active standing committee in the hospital, nursing or hospice care facility which is the organizational line of communication and liaison between the medical and pharmacy staff which acts to review and promote rational drug therapy and utilization in the licensed facility.119. "Pharmacy technician" means an individual who meets minimum qualifications established by the Board, that are less than those established by the Act as necessary for licensing as a pharmacist; and who work under the direction and supervision of a licensed pharmacist. There shall be two (2) levels of licensure for Pharmacy Technicians:a. Pharmacy Technician I; andb. Pharmacy Technician II. (See also §1.1.10 of this Part). As used in these Regulations, a "Pharmacy Technician II" is one who is licensed by the Board as a Pharmacy Technician and who is also currently certified by the Pharmacy Technician Certification Board (PTCB) of the American Pharmacists' Association or other national certifying organization as may be approved by the Board.120. "Practice of pharmacy" means the interpretation, evaluation and implementation of medical orders; the dispensing of prescription drug orders; participation in drug and device selection; drug regimen reviews and drug or drug related research as well as medication therapy management (MTM); the participation in collaborative practice; the administration of medications; the administration of immunizations pursuant to a valid prescription or prescriber-approved protocol and in accordance with Regulations, to include training requirements, as promulgated by the Department; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for the supervision for compounding and labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of non-prescription drugs and commercially packaged legend drugs and devices) proper and safe storage of drugs and devices; and maintenance of proper records for them and the performance of clinical laboratory tests provided such testing is limited to limited-function tests as defined in this Part. Nothing in this definition shall be construed to limit or otherwise affect the scope of practice of any other profession.121. "Practitioner" means a physician, physician assistant, dentist, veterinarian, nurse or other person duly authorized by law in the State in which he/she practices to prescribe drugs.122. "Preceptor" means a pharmacist licensed to engage in the practice of pharmacy in the State of Rhode Island or a licensed pharmacist in the USA who has the responsibility for training interns.123. "Prescription" means an order for drugs or devices issued by the practitioner duly authorized by law in the State in which he/she practices to prescribe drugs or devices in the course of his/her professional practice for a legitimate medical purpose.124. "Prescription sample" means a complimentary drug packaged in accordance with federal and state statutes and provided to a licensed practitioner free of charge by manufacturers.125. "Prescription drug" or "Legend drug" means a drug which, under Federal law, is required, prior to being dispensed or delivered, to be labeled with either of the following statements: b. "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; orc. A drug which is required by any applicable Federal or State law or Rule to be dispensed pursuant only to a prescription, or is restricted to use by practitioners only, and includes finished dosage forms and active ingredients subject to §503(b) of the Federal Food, Drug, and Cosmetic Act, including all medical gases.126. "Product liability", as used herein, means insurance coverage protecting the Canadian pharmacy against legal liability resulting from a defective condition causing bodily injury, or damage, to any individual or entity, associated with the use of the product.127. "Prospective drug review" means a review of the patient's drug therapy record and prescription, as established in the rules of the Board, prior to dispensing the drug as part of a drug regimen review.128. "PTCB" means Pharmacy Technician Certification Board.129. "Qualified licensed professional" means a non-pharmacist individual (such as physician, nurse, physician assistant or technologist) who possesses a current State license, if applicable, and who has sufficient training and experience to safely handle and dispense radiopharmaceuticals as defined by the respective requirements of the Rhode Island Rules and Regulations for the Control of Radiation Healthcare, Subchapter 20 of this Chapter and R.I. Gen. Laws Chapter 23-1.3.130. "Qualified nuclear pharmacist" means a currently licensed pharmacist in the state of Rhode Island, who is identified as an Authorized Nuclear Pharmacist on a radioactive materials license issued pursuant to Subpart C.8 of the "Rules and Regulations for the Control of Radiation [R 23-1.3 -RAD]" or equivalent Regulations of the U.S. Nuclear Regulatory Commission or another Agreement State.131. "Reasonable effort" includes collecting patient information with printed data forms provided to the patient by the pharmacist, the pharmacist interviewing the patient to develop a patient's medication history, or similar patient-pharmacist interactions where the pharmacist assumes responsibility to collect, record, and maintain information necessary to properly dispense a prescription and counsel a patient. Collection of patient information may be appropriately delegated by the responsible pharmacist.132. "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history and the keeping of proper records.133. "Radiopharmaceuticals" are radioactive drugs as defined by the FDA and regulated pursuant to R.I. Gen. Laws Chapter 23-1.3 and the "Rules and Regulations for the Control of Radiation [R 23-1.3 -RAD]."134. "Radiopharmaceutical service" means, but is not limited to, the procurement, storage, handling, preparation, labeling, quality assurance testing, dispensing, delivery, record keeping, and disposal of radiopharmaceuticals and other drugs.135. "Recognized provider" means any person, corporation or association approved either by the Board, the Accreditation Council for Pharmaceutical Education (ACPE), or American Medical Association (AMA) Category I Programs, to conduct continuing education programs.136. "Restricted pharmacy" is a facility established pursuant to R.I. Gen. Laws § 5-19.1-10, and the provisions of the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001et seq., for the purposes of dispensing drugs to the beneficiaries of any trust, fund, pension plan, combination plan, or profit sharing plan.137. "Retail pharmacy" means any pharmacy where drugs are compounded, dispensed, stored or sold or where prescriptions are filled or dispensed to the general public.138. "Retrospective drug review" means the monitoring for therapeutic appropriateness, over-utilization and under-utilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dosage or duration of drug treatment, and clinical abuse/misuse after the drug has been dispensed.139. "Shared order filling" means that the functions of: preparation, packaging, compounding, or labeling of an order or any combination of these functions by an authorized person located at a pharmacy on behalf of and at the request of another pharmacy; and returning the filled order to the requesting pharmacy for delivery to the patient or patient's agent or, at the request of the delivery pharmacy, directly delivering the filled order to the patient, or an alternate location of the patient's choosing.140. "Shared order processing" means that the functions of: interpreting and entering the order, performing drug utilization reviews, refill authorizations, or therapeutic interventions, or any combination of these functions are performed in accordance with the Act and these Regulations, and are performed at a licensed pharmacy at the request of, and on behalf of, another pharmacy.141. "Shared pharmacy services" means a system that allows a participating pharmacist or pharmacy pursuant to a request from another participating pharmacist or pharmacy to process or fill a Prescription Drug Order, which may include preparing, packaging, labeling, compounding for specific patients, dispensing, performing Drug Utilization Reviews, reviewing therapeutic interventions, and/or reviewing institutional facility orders.142. "Shared services pharmacy" means both central fill and delivery pharmacies that have the same owner, or have a written contract outlining the services provided and the shared responsibilities of each party in accordance with the Act and this Part, and that participate in shared order filling or shared order processing, or both.143. "Sterile compounding" means any manipulation of a sterile or non-sterile product intended to produce a sterile final product.144. "Standing order" means a prewritten medication, medical supply(ies) or equipment order with specific instructions from a licensed independent practitioner to administer, prescribe or dispense a medication, supplies, or equipment to a person in clearly defined circumstances.145. "Substance abuse facility" means a facility licensed by the State Department of Behavioral Healthcare, Developmental Disabilities and Hospitals that includes residential treatment services and detoxification services.146. "Supply" means the delivery of a non-controlled medication to a patient by a practitioner by one (1) of the following methods and in accordance with the requirements stated herein: a. Pre-packaged prescription sample medication;b. Automated dispensing system;c. Administration of a stock medication;d. Dispensing of a manufacturer-prepared pap medication;e. Dispensing of oral and transdermal contraceptives.147. "Unit-dose container" is one that is designed to hold a quantity of drug intended for use as a single dose and used promptly after the container is opened. The immediate container, and/or the outer container or protective packaging shall be designed to show evidence of any tampering with the contents. Each individual container shall be fully identifiable containing a single dose of a single entity and shall protect the integrity of the dosage form. Labeling shall be in accordance with USP standards compendia and Federal and State law and shall include the identity, quantity, and strength of the product, name of the manufacturer, and lot number and expiration date of the article.148. "USP" means the United States Pharmacopeia.149. "Wholesale distribution" means distribution of prescription drugs to person other than a consumer or patient, but does not include: b. The purchase or other acquisition by a hospital or other healthcare entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or healthcare entities that are members of such organizations;c. The sale, purchase or trade of a drug of an offer to sell, purchase, or trade a drug by a charitable organization to a non-profit affiliate of the organization to the extent otherwise permitted by law;d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other healthcare entities that are under common control. For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;e. The sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons. For purposes of this section, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;f. The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;g. The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives;h. The sale, purchase, or trade of blood and blood components intended for transfusion;i. Every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17 that is required to restock supplies listed by the Director of Health that are used by a licensed emergency medical services provider in transporting emergency patients to such hospital, pursuant t o R.I. Gen. Laws § 23-4.1-7.1.j. Every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17 that accepts vaccine from the Department and distributes such vaccine as part of the Department's immunization program.150. "Wholesale distributor" means anyone engaged in wholesale distribution of drugs, including, but not limited to, manufacturers, repackers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses, independent wholesale drug traders, and retail pharmacies that conduct wholesale distribution.151. "Wholesaler" means a person who buys drugs or devices for resale and distribution to corporations, individuals, or entities other than consumers.216 R.I. Code R. § 216-RICR-40-15-1.2
Amended effective 5/17/2021
Amended effective 12/8/2022